ASTRIS-UK: Antithrombotic treatment patterns and risk of STroke Recurrence or major bleeding in patients with non-cardioembolic Ischemic Stroke from the UK

Study type
Protocol
Date of Approval
Study reference ID
23_003598
Lay Summary

Stroke (also known as brain attack) occurs when blood cannot get to your brain and represents a serious health problem worldwide. Even though management and treatment of this condition has improved in recent years, the risk of having a new stroke is still a big challenge. People who have a stroke that is somehow related to heart disease need different care than those with a stroke not related to heart disease. Thus, these two types of events must be studied separately. This study wants to find out how likely it is for someone to have a new stroke or a major bleeding problem after leaving the hospital for a stroke that was unrelated to heart disease. We are going to look at data from a UK health database to do this. We will track people with a stroke since they leave hospital until they have a new stroke, a major bleeding issue, or die. We will also study how sex, age, lifestyle, or previous health problems have an influence on what happens to these patients. We will also describe what kind of medicines they take to prevent these problems. By doing this, we hope to learn more about how often strokes happen again and how well treatments work. This information can help patients, doctors, and health planners make better decisions.

Technical Summary

Ischemic stroke (IS) is a major cause of mortality and morbidity worldwide. Despite advances in acute stroke management, the risk of recurrent stroke still poses a significant challenge. Management of individuals who experience a cardiogenic IS differs greatly from those experiencing a non-cardioembolic stroke. This study aims to explore the risk of recurrent IS and major bleeding events after a discharge for a non-cardioembolic IS. To estimate the occurrence and explore the determinants of these events (including the antithrombotic therapy initiated after the index IS) we plan to conduct a retrospective cohort study using CPRD-Aurum database from the UK, along with linked HES databases. We will identify hospital admissions compatible with non-cardiogenic IS recorded on HES during the study period (1/1/2012-28/02/2020). We will follow individuals starting 15 days after discharge until the occurrence of each study endpoint: a) Recurrent IS, Intracranial bleed, c) Stroke, d) Major bleed, and e) All cause death. We will estimate the incidence rate of these study events and describe patients’ characteristics including demographics, lifestyle factors, comorbidity and healthcare utilization at baseline (index IS event) as well as at time of recurrence among those patients experience a recurrent IS event. Patterns of antithrombotic use will also be described at various time points before and after the index IS event, and also after an IS recurrence. Survival analyses will be performed to explore time to the occurrence of the study endpoints and to assess the determinants of these events. Multivariable adjusted Cox proportional hazards regression models will be used to this end. In summary, this study will update our knowledge about stroke recurrence and patterns of preventive treatment in recent years concerning non-cardioembolic stroke. We believe this will be of importance to patients, their physicians, and health planners.

Health Outcomes to be Measured

Recurrent IS; Intracranial bleed; Stroke (both ischemic or hemorrhagic); Major bleed; All cause death

Collaborators

Kristian Tore Jørgensen - Chief Investigator - Bayer A/S - Denmark
Luis Alberto Garcia Rodriguez - Corresponding Applicant - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )
Antonio Gonzalez Perez - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )
Oscar Fernández Cantero - Collaborator - Centro Español de Investigaciones Farmacoepidemiológicas S.L. ( CEIFE S.L. )

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;ONS Death Registration Data;Patient Level Townsend Index